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Checkpoint and Alco-Breath Tube Receive FDA Clearance

The CheckPoint breath alcohol test and the Alco-Breath Tube alcohol test received FDA 510-k clearance in April 2011. The FDA clearance is for over-the-counter (OTC) use, which means that the devices may be sold directly to consumers. By regulation, devices that have FDA over-the-counter clearance also have CLIA waived status.

To receive FDA clearance AlcoPro demonstrated to the FDA that untrained users could learn to use the devices and get accurate results just by reading the instructions. Our customers will appreciate the additional information and illustrations in the new instruction sheets that provide much clearer directions for using the devices and interpreting the results.